Label: DULCOLAX LIQUID- magnesium hydroxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 29, 2021

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  • SPL UNCLASSIFIED SECTION

    Dulcolax®

    Liquid Saline Laxative – Mint

    Drug Facts

  • Active ingredient (in each 15 mL)

    Magnesium hydroxide USP 1200 mg

  • Purpose

    Saline laxative

  • Use

    ● for relief of occasional constipation and irregularity

    ● this product generally produces bowel movement in ½ to 6 hours

  • Warnings

    Ask a doctor before use if you have

    ● kidney disease

    ● a magnesium-restricted diet

    ● stomach pain, nausea or vomiting

    ● noticed a sudden change in bowel habits that lasts more than 2 weeks

    Ask a doctor or pharmacist before use if you are 

    taking a prescription drug. This product may interact with certain prescription drugs.

    Stop use and ask a doctor if

    ● you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.

    ● you need to use a laxative for more than 1 week

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    ● shake well immediately before each use

    ● for accurate dosing, use convenient pre-measured dose cup

    ● drink a full glass (8 oz) of liquid with each dose

    ● dose may be taken as a single daily dose or in divided doses

    ● do not exceed the maximum recommended daily dose in a 24 hour period

    adults and children 12 years of age and over             30 mL to 60 mL

    children 6 to under 12 years of age                    15 mL to 30 mL

    children 2 to under 6 years of age                   5 mL to 15 mL

    children under 2 years of age                         ask a doctor

  • Other information

    ● each 15 mL contains: 

    calcium 20 mg, magnesium 595 mg, sodium 2 mg

    ● do not use if safety seal is broken or missing 

    ● close cap tightly after each use

    ● store at room temperature 20°-25°C (68°-77°F). Avoid freezing.

  • Inactive ingredients

    flavor, mineral oil, purified water, saccharin sodium

    Questions? Call 1-866-844-2798 or visit www.Dulcolax.com

  • PRINCIPAL DISPLAY PANEL

    Stimulant-Free
    Dulcolax
    Magnesium Hydroxide 1200 mg per 15 mL Saline Laxative
    MINT Flavor

    12 Fl Oz (354 mL)

    Stimulant-Free Dulcolax Magnesium Hydroxide 1200 mg per 15 mL Saline Laxative MINT Flavor 12 Fl Oz (354 mL)

  • INGREDIENTS AND APPEARANCE
    DULCOLAX  LIQUID
    magnesium hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0292
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINT (UNII: FV98Z8GITP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0292-0354 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33403/01/2019
    Labeler - Chattem, Inc. (003336013)
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